Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery (NCT03893734)
🩺 Plain-English Summary (8th-Grade Level)
A number of drugs used in the perioperative period may cause prolongation of the QT interval on the electrocardiogram (EKG). These drugs include inhalational agents, antiemetic agents, pain medications, and drugs used to reverse the effects of muscle relaxants. Approximately 80% of patients undergoing a general anesthetic will demonstrate significant prolongation of the QT interval on the EKG in the postanesthesia care unit (PACU) following surgery. The concern with QT interval prolongation is that it can result in a potentially lethal ventricular arrhythmia termed torsade des pointes. Despite the concurrent use of several of these medications in a typical general anesthetic, torsade des pointes is a rare event in the perioperative period. In the past decade, the use of intravenous methadone as part of a balanced anesthetic technique has increased significantly. A single dose provided at induction of anesthesia can provide prolonged (24-48 hours) relief from pain. Studies in patients receiving long-term treatment with methadone for addiction therapy or chronic pain have revealed that these patients are at risk for QT prolongation, torsade des pointe, and cardiac death. However, the effect of a single intravenous dose of methadone used in the operating room on the QT interval is uncertain. The aim of this randomized clinical trial is to compare the impact of methadone, when compared to the more commonly-used opioid hydromorphone, on QT prolongation measured with a 12-lead EKG in the PACU and on postoperative day 1. We hypothesize that methadone will not result in significant QT prolongation when used as part of a standardized general anesthetic.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (7 items).
Location: NorthShore University HealthSystem — Evanston, Illinois
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History of arrhythmias, pacemaker, or defibrillator
- Allergy to methadone or hydromorphone
- Preoperative altered mental status
- Abnormal serum electrolyte values
- Existence of significant valvular disease or cardiac rhythm other than sinus
- Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- NorthShore University HealthSystem — Evanston, Illinois
📞 Contact the Study Coordinator
Phone: (264) 364-7272
Email: lklatzco@northshore.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All EKG-QT Prolongation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.